Syndesmosis Fixation Assembly

ABSTRACT

Syndesmosis fixation assemblies, systems, and methods thereof. A syndesmosis fixation assembly includes a suture retaining portion having a plurality of suture openings formed therein and a suture securing portion rotatably connected to the suture retaining portion. The suture securing portion is movable between a first position wherein a suture is moveable within the suture retaining portion and a second position wherein the suture is frictionally secured within the suture retaining portion. A bone insertion portion has a distal bone insertion end adapted for insertion into a bone, a proximal bone insertion end connected to the suture retaining portion, and a central longitudinal axis extending between the distal bone insertion end and the proximal bone insertion end.

CROSS-REFERENCE TO RELATED APPLICATION(S)

The present application is a continuation of U.S. patent applicationSer. No. 16/717,589, filed on Dec. 17, 2019 (published as U.S. Pat. Pub.No. 2021-0177394), the entire contents of which is hereby incorporatedby reference in its entirety for all purposes.

BACKGROUND Field

The present device relates to constructs that are used in the fixationof syndesmosis disruptions.

Description of the Related Art

A present method for syndesmotic ankle fixation requires screws orsuture button systems. Both types of these fixation devices are insertedthrough the fibula and into the syndesmosis. The cross section of thefibula is relatively small, particularly at the syndesmosis, which canresult in the clinician having a difficult time inserting the screw orsuture button system through the fibula.

Accordingly, there exists a need for a syndesmosis fixation system thatdoes not extend through the fibula.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter.

According to one embodiment, a syndesmosis fixation assembly may includea plurality of implantable devices configured to aid in anatomicreduction.

In one embodiment, the syndesmosis fixation assembly may include asuture retaining portion having a plurality of suture openings formedtherein and a suture securing portion rotatably connected to the sutureretaining portion. The suture securing portion is movable between afirst position wherein a suture is moveable within the suture retainingportion and a second position wherein the suture is frictionally securedwithin the suture retaining portion. A bone insertion portion has adistal bone insertion end adapted for insertion into a bone, a proximalbone insertion end connected to the suture retaining portion, and acentral longitudinal axis extending between the distal bone insertionend and the proximal bone insertion end.

In an alternative embodiment, the syndesmosis fixation assembly includesa suture retaining portion having a plurality of suture openings formedtherein and a suture extending through each of the plurality of sutureopenings. A suture securing portion is connected to the suture retainingportion. The suture securing portion is movable between a first positionwherein the suture is moveable within the suture retaining portion and asecond position wherein the suture is frictionally secured within thesuture retaining portion. A bone insertion portion has a distal boneinsertion end adapted for insertion into a bone and a proximal boneinsertion end connected to the suture retaining portion.

In still another alternative embodiment, the syndesmosis fixationassembly comprises a suture retaining portion and a suture securingportion adapted to move from a first position wherein a suture in thesuture retaining portion is moveable with respect to the sutureretaining portion and a second position wherein the suture is fixed withrespect to the suture retaining portion. A bone insertion portion has adistal portion adapted for insertion into a bone and a proximal portionconnected to the suture retaining portion.

BRIEF DESCRIPTION OF THE DRAWINGS

Other aspects, features, and advantages of the present device willbecome more fully apparent from the following detailed description, theappended claims, and the accompanying drawings in which like referencenumerals identify similar or identical elements.

FIG. 1 is a sectional view showing an exemplary method of reducing asyndesmosis according to the exemplary embodiments;

FIG. 2 is an exploded view of a fixation assembly according to anexemplary embodiment;

FIG. 3 is a sectional view of the assembly of FIG. 2 in a suture releaseposition;

FIG. 4 is a sectional view of the assembly of FIG. 2 in a suturerestraining position;

FIG. 5 is a perspective view of a fixation assembly according to analternative exemplary embodiment;

FIG. 6 is a sectional view of the assembly of FIG. 5 in a suture releaseposition;

FIG. 7 is a sectional view of the assembly of FIG. 5 in a suturerestraining position;

FIG. 8 is a side elevational view of a fixation assembly according to analternative exemplary embodiment;

FIG. 9 is a sectional view of the assembly of FIG. 8 in a suture releaseposition;

FIG. 10 is a sectional view of the assembly of FIG. 8 in a suturerestraining position;

FIG. 11 is a side elevational view of a fixation assembly according toan alternative exemplary embodiment;

FIG. 12 is a side elevational view of the assembly of FIG. 11 withanchor legs in a deployed position;

FIG. 13 is a sectional view of the assembly of FIG. 11 with the anchorlegs in the deployed position;

FIG. 14 is a perspective view of the anchor used with the assembly ofFIG. 11 ;

FIG. 15 is a side elevational view of a fixation assembly according toan alternative exemplary embodiment;

FIG. 16 is a side elevational view of the assembly of FIG. 15 withanchor legs in a deployed position;

FIG. 17 is a sectional view of the assembly of FIG. 15 with the anchorlegs in the deployed position;

FIG. 18 is a perspective view of the assembly of FIG. 15 with theanchors deployed;

FIG. 19 is a perspective view of a fixation device according to analternative exemplary embodiment;

FIG. 20 is a perspective view of a fixation device according to anotheralternative exemplary embodiment;

FIG. 21 is a sectional view of the device of FIG. 20 ;

FIG. 22 is a perspective view of a pair of fixation assemblies accordingto an alternative exemplary embodiment embedded in a tibia and used toreduce a syndesmosis;

FIG. 23 is a perspective view of a washer with a buckle used with theassembly of FIG. 22 ;

FIG. 24 is a sectional view of the assembly of FIG. 22 ;

FIG. 25 is a perspective view of a fixation device according to analternative embodiment;

FIG. 26 is a side elevational view, in section, of a washer with a camoperated buckle in a release position according to an alternativeexemplary embodiment;

FIG. 27 is a side elevational view, in section, of the washer with amoperated buckle of FIG. 26 in a locking position;

FIG. 28 is a sectional view showing an exemplary method of reducing asyndesmosis according to an alternative exemplary embodiment;

FIG. 29 is a sectional view of the embodiment of FIG. 28 with a clampconnecting two sutures;

FIG. 30 is a perspective view of an exemplary clamping tool used toclamp the clamp of FIG. 29 ;

FIG. 31 is a top plan view of a staple inserted into the clamp of FIG.30 ;

FIG. 32 is a top plan view of the clamp and staple of FIG. 31 havingclamped down on the staple; and

FIG. 33 is a schematic view of a fixation assembly according to analternative exemplary embodiment.

DETAILED DESCRIPTION

In the drawings, like numerals indicate like elements throughout.Certain terminology is used herein for convenience only and is not to betaken as a limitation on the present device. The terminology includesthe words specifically mentioned, derivatives thereof and words ofsimilar import. As used herein, the term “proximal” is intended to meana direction closer to a clinician implanting the inventive devices andthe term “distal” is intended to mean a direction farther from theclinician.

The embodiments illustrated below are not intended to be exhaustive orto limit the device to the precise form disclosed. These embodiments arechosen and described to best explain the principle of the device and itsapplication and practical use and to enable others skilled in the art tobest utilize the device.

Reference herein to “one embodiment” or “an embodiment” means that aparticular feature, structure, or characteristic described in connectionwith the embodiment can be included in at least one embodiment of thedevice. The appearances of the phrase “in one embodiment” in variousplaces in the specification are not necessarily all referring to thesame embodiment, nor are separate or alternative embodiments necessarilymutually exclusive of other embodiments. The same applies to the term“implementation.”

As used in this application, the word “exemplary” is used herein to meanserving as an example, instance, or illustration. Any aspect or designdescribed herein as “exemplary” is not necessarily to be construed aspreferred or advantageous over other aspects or designs. Rather, use ofthe word exemplary is intended to present concepts in a concretefashion.

Additionally, the term “or” is intended to mean an inclusive “or” ratherthan an exclusive “or”. That is, unless specified otherwise, or clearfrom context, “X employs A or B” is intended to mean any of the naturalinclusive permutations. That is, if X employs A; X employs B; or Xemploys both A and B, then “X employs A or B” is satisfied under any ofthe foregoing instances. In addition, the articles “a” and “an” as usedin this application and the appended claims should generally beconstrued to mean “one or more” unless specified otherwise or clear fromcontext to be directed to a singular form.

Unless explicitly stated otherwise, each numerical value and rangeshould be interpreted as being approximate as if the word “about” or“approximately” preceded the value of the value or range.

The use of figure numbers and/or figure reference labels in the claimsis intended to identify one or more possible embodiments of the claimedsubject matter in order to facilitate the interpretation of the claims.Such use is not to be construed as necessarily limiting the scope ofthose claims to the embodiments shown in the corresponding figures.

It should be understood that the steps of the exemplary methods setforth herein are not necessarily required to be performed in the orderdescribed, and the order of the steps of such methods should beunderstood to be merely exemplary. Likewise, additional steps may beincluded in such methods, and certain steps may be omitted or combined,in methods consistent with various embodiments of the present device.

Although the elements in the following method claims, if any, arerecited in a particular sequence with corresponding labeling, unless theclaim recitations otherwise imply a particular sequence for implementingsome or all of those elements, those elements are not necessarilyintended to be limited to being implemented in that particular sequence.

Also for purposes of this description, the terms “couple,” “coupling,”“coupled,” “connect,” “connecting,” or “connected” refer to any mannerknown in the art or later developed of joining or connecting two or moreelements directly or indirectly to one another, and the interposition ofone or more additional elements is contemplated, although not required.Conversely, the terms “directly coupled,” “directly connected,” etc.,imply the absence of such additional elements.

The present disclosure provides embodiments of fixation deviceassemblies that can be used in syndesmosis fixation. The devices andassemblies described herein can be attached to a tibia 40 in twolocations, with a suture 50 or suture tape connected to each device andwrapped around a fibula 42 to stabilize the syndesmosis. A simplifiedillustration of fixation device assemblies described herein is shown inFIG. 1 , using generic screws 30 implanted into a tibia 40 on eitherside of a fibula 42, with a suture 50 or suture tape 52 connected toscrews 30 and wrapped over fibula 42 to draw fibula 42 closer to tibia40 and reduce the syndesmosis.

Referring to FIGS. 2-4 , a syndesmosis fixation assembly 100 (“assembly100”) according to a first exemplary embodiment is shown. Assembly 100includes a suture retaining portion 110, a suture securing portion 140,and a bone insertion portion 180. Assembly 100 is cannulated along acentral longitudinal axis 102 to allow for the optional use of a guidewire through assembly 100 to assist in inserting assembly 100 into bone.

Suture retaining portion 110 includes a generally hollow body 112 havinga proximal portion 114, a distal portion 116, and an intermediateportion 118, between the proximal portion 114 and the distal portion116. Proximal portion 114 includes a cavity 119 having internal threads120 that are sized to mate with external threads 142 on suture securingportion 140.

Distal portion 116 includes a plurality of distally extending fingers122 that are separated from adjacent fingers 122 by a longitudinal gap124. Fingers 122 form an internal space 125 in distal portion 116. In anexemplary embodiment, four fingers 122 are provided, although thoseskilled in the art will recognize that more or less than four fingers122 can be provided. A distal end of each finger 122 includes aninternal lip 126 that is used to engage bone insertion portion 180.Internal space 125 has an internally extending radial lip 128 thatnarrows internal space 125 in a proximal direction.

Intermediate portion 118 includes a plurality of suture openings 130formed therein. In an exemplary embodiment, suture openings 130 includea first suture opening 130 a and a second suture opening 130 b that arediametrically opposed from each other.

Suture securing portion 140 comprises a set screw that is insertableinto cavity 119 and is movable between a first position, shown in FIG. 2, wherein a suture 50 is moveable within the suture retaining portionand a second position, shown in FIG. 3 , wherein the suture 50 isfrictionally secured within suture retaining portion 110.

Bone insertion portion 180 includes a distal bone insertion end 182 thatis adapted for insertion into a bone. Distal bone insertion end 182includes a threaded portion 184 for gripping the bone.

Bone insertion portion 180 also includes a proximal bone insertion end186 connected to suture retaining portion 110. Proximal bone insertionend 186 includes a radially extending lip 188 that is used to retainsuture retaining portion 110. A hex head 190 is located proximally oflip 188 and is used to insert bone insertion portion 180 into a bone.

To insert assembly 100, bone insertion portion 180 is threaded sub-flushinto bone, either using a guide wire (not shown) or, alternatively,without a guide wire. A suture 50 is inserted into first suture opening130 a through suture retaining portion 110 and out second suture opening130 b.

Suture retaining portion 110 is secured onto proximal bone insertion end186 such that lip 126 on suture retaining portion 110 is forced over lip188 on bone insertion portion 180 to rotatably secure suture retainingportion 110 onto bone insertion portion 180. Suture 50 can be tensionedby pulling on a free end 58.

Suture securing portion 140 can be screwed down into cavity 119 tofrictionally secure suture 50 within suture retaining portion 110.

Referring to FIGS. 5-7 , a syndesmosis fixation assembly 200 (“assembly200”) according to an alternative exemplary embodiment is shown.Assembly 200 includes a suture retaining portion 210, a suture securingportion 240, and a bone insertion portion 280.

Suture retaining portion 210 includes a generally hollow body 212 havinga proximal portion 214 and a distal portion 216. Proximal portion 214includes a cavity 219 having internal threads 220 that are sized to matewith external threads 242 on suture securing portion 240. Proximalportion 214 also includes a plurality of suture openings 218 extendingtherethrough. Proximal portion 214 also includes a cap 215.

Distal portion 216 includes a head 222 having a circular outer perimeter223 and a threaded body 224 having a narrower cross section than head222. Head 222 has a cavity 225 adapted to receive an insertion tool 206to rotate head 222. In an exemplary embodiment, cavity 225 accepts a hexhead driver. Head 222 is sized to fit within cap 215 so that head 222rotatably engages cap 215. Threaded body 224 is sized to internallythread into a proximal threaded cavity 285 in a proximal bone insertionend 283 of bone insertion portion 280.

Suture securing portion 240 comprises a set screw 242 that is insertableinto cavity 219 and is movable between a first position, shown in FIG. 6, wherein a suture is moveable within suture retaining portion 210 and asecond position, shown in FIG. 7 , wherein the suture can befrictionally secured within suture retaining portion 110. Set screw 242is generally hollow with an internal hex face 244 and a distal end 248.

Bone insertion portion 280 includes a distal bone insertion end 282 thatis adapted for insertion into a bone. Distal bone insertion end 282includes a threaded portion 284 for gripping the bone. A centrallongitudinal axis 292 extends between distal bone insertion end 282 andproximal bone insertion end 283.

Suture securing portion 240 is threadingly disposed in cavity 219 andmovable between a first position wherein the suture is moveable withinsuture retaining portion 210 and a second position wherein the suture isfrictionally secured within suture retaining portion 210. The firstposition is a distal position relative to bone insertion portion 280 andthe second position is a proximal position relative to the boneinsertion portion 280.

To insert assembly 200, head 222 is inserted through cap 215 such thatthreaded body 224 extends distally from cap 215. A suture (not shown) ininserted into one suture opening 218 and out another suture opening 218.A retaining tool 202 is inserted over suture retaining portion so thatnubs 204 on distal ends of retaining tool 202 are inserted intodiametrically opposing suture openings 218 and help to prevent rotationof cap 215 and the suture as assembly 200 is driven into the bone.

Next, threaded body 215 is inserted into threaded cavity 285 in proximalbone insertion end 283 of bone insertion portion 280 and bone insertionportion 280 is driven into a bone using a driver 206 inserted into head222. Then, an outer driver 208 is used to rotate set screw 242 distallyfrom the position shown in FIG. 6 to the position shown in FIG. 7 untildistal end 248 of set screw 242 engages the top of head 222, therebysecuring the suture between set screw 242 and head 222.

Referring to FIGS. 8-10 , a syndesmosis fixation assembly 300 (“assembly300”) according to an alternative exemplary embodiment is shown.Assembly 300 includes a suture retaining portion 310, a suture securingportion 340, and a bone insertion portion 380.

Suture retaining portion 310 includes a generally hollow body 312 havinga proximal portion 314 and a distal portion 316. Proximal portion 314includes internal threads 317 that accepts an insertion tool 302.Proximal portion 314 also includes a plurality of suture openings 318extending therethrough. The plurality of suture openings 318 comprises afirst opening 318 a and a second opening 318 b, proximal of firstopening 318 a.

Distal portion 316 includes a cap 322 that is sized to receive suturesecuring portion 340 to frictionally engage a suture 50 that extendsfrom suture openings 318 a, 318 b. A lip 324 extends radially inwardlyfrom cap 322.

Suture securing portion 340 comprises a head 342 adapted to receive aninsertion tool 304 to rotate head 342. In an exemplary embodiment, head342 accepts a hex head driver. Head 342 ends in an annular shoulder 344that engages insertion tool 304. Head 342 includes a bulbous body 348extending distal of shoulder 344, with a circumferential groove 350formed therein. A passage 351 is provided between body 348 and sutureretaining portion 310 from first suture slot 318 a to second suture slot318 b so that suture 50 can be slid along passage 351.

A distal end 352 of suture securing portion 340 includes a threaded body360 that is sized to internally thread into a proximal threaded cavity385 in a proximal bone insertion end 383 of bone insertion portion 380.A lip 388 extends around distal end 352 between threaded body 360 andhead 342.

Bone insertion portion 380 includes a distal bone insertion end 382 thatis adapted for insertion into a bone. Distal bone insertion end 382includes a threaded portion 384 for gripping the bone. A centrallongitudinal axis 392 extends between distal bone insertion end 382 andproximal bone insertion end 383.

Suture securing portion 340 is disposed in suture retaining portion 310such that and movable between a first position wherein suture 50 ismoveable within suture retaining portion 310 and a second positionwherein suture 50 is frictionally secured suture retaining portion 310and suture securing portion 340. The first position is a distal positionrelative to bone insertion portion 380 and the second position is aproximal position relative to the bone insertion portion 380.

Referring to FIGS. 9 and 10 , to insert assembly 300, threaded body 360of suture securing portion 340 is inserted through cap 322 such thatthreaded body 360 extends distally from cap 322 so that lip 324 isdistal of lip 388. A suture 50 in inserted into one suture opening 218 aand out another suture opening 218 b.

A first retaining tool 302 is threaded onto internal threads 317 ofproximal portion 314 to prevent rotation of suture retaining portion310. A second retaining tool 304 is inserted into first retaining tool302 and over head 342 until second training tool engages shoulder 344.

Next, threaded body 360 is inserted into threaded cavity 385 in proximalbone insertion end 383 of bone insertion portion 380 and bone insertionportion 380 is driven into a bone using a driver 304 inserted over head342 until bone insertion portion is sub-flush with bone. Both drivers302, 304 can then be removed.

To frictionally secure suture 50, cap 322 is pulled proximally in thedirection of arrow “A” in FIG. 9 so that lip 324 snaps over lip 388 andremains proximally over lip 388. Suture retaining portion 310 engageshead 342 so that passage 351 is reduced, thereby frictionally securingsuture 50 between body 348 of head 342 and suture retaining portion 310.

Referring to FIGS. 11-14 , a syndesmosis fixation assembly 400(“assembly 400”) according to an alternative exemplary embodiment isshown. Assembly 400 includes a suture retaining portion 410, a suturesecuring portion 420, and a bone insertion portion 440.

Suture retaining portion 410 includes a plurality of distally extendingfingers 412 that are separated from adjacent fingers 412 by alongitudinal gap 414. Fingers 412 form an internal space 415 in sutureretaining portion 410. In an exemplary embodiment, four fingers 412 areprovided, although those skilled in the art will recognize that more orless than four fingers 412 can be provided.

Internal space 415 has an internal thread 416 to threadingly accept andengage suture securing portion 420. Internal space 415 bottoms out on alanding 417. Suture retaining portion 410 also includes external ribbing418 that allows assembly 400 to be inserted into a pre-drilled hole (notshown) but resists being pulled out.

Suture securing portion 420 includes a deformable spring anchor 422 thatserves as both suture securing portion 420 as well as an anchor tosecure assembly 400 in bone. Spring anchor 422 includes a body portion424 with a plurality of anchor legs 426 extending outwardly therefrom.The number of anchor legs 426 is the same number as the number oflongitudinal gaps 414 such that each anchor leg 424 extends into arespective gap 414, while body portion 424 can slide within internalspace 415.

Suture securing portion 420 further includes a set screw 428 that isinsertable into internal space 415. Set screw 428 has a blunt distal tip430 and a proximal head 432 that is configured to accept a driver (notshown) for rotating set screw 428 distally into internal space 415. Setscrew 428 has an external thread 434 that mates with internal thread 416to advance set screw 428 distally.

Bone insertion portion 440 extends distally from suture retainingportion 410 and includes a blunt distal tip 442 and external ribbing 444that is an extension of the external ribbing 418 on suture retainingportion 410.

In an insertion condition, anchor legs 426 are stored within theperimeter of fingers 412, as shown in FIG. 11 . A suture (not shown) canbe inserted into suture retaining portion 410 such that each end of thesuture extends outwardly of one of gaps 414. Bone securing portion 440is inserted into the bone and set screw 428 is advanced distally intointernal space 415, driving anchor 422 distally until anchor 422frictionally engages the suture between anchor body portion 424 andlanding 417 of internal space 415.

As set screw 428 is further advanced distally, anchor legs 426 aredeformed to splay outwardly from the stored position, as shown in FIG.11 , to a deployed position, as shown in FIGS. 12 and 13 .

Referring to FIGS. 15-18 , a syndesmosis fixation assembly 450(“assembly 450”) according to an alternative exemplary embodiment isshown. Assembly 450 includes a suture retaining portion 460, a suturesecuring portion 470, and a bone insertion portion 490.

Suture retaining portion 460 includes a plurality of distally extendinggenerally semi-circular leg portions 462 that are separated from eachother by a pair of diametrically opposed longitudinal gaps 464. Legportions 462 form an internal space 465 in suture retaining portion 460.In an exemplary embodiment, two diametrically opposed leg portions 462are provided, although those skilled in the art will recognize that moreor less than two leg portions 462 can be provided.

Internal space 465 has an internal thread 466 to threadingly accept andengage suture securing portion 470. Internal space 465 bottoms out on alanding 467. A pair of diametrically opposed suture slots 468 extendfrom internal space 465 through each leg portion 462. Suture slots 468are generally rectangular in cross section and are sized to allow asuture (not shown) to extend therethrough. Suture retaining portion 460also includes external ribbing 469 that allows assembly 450 to beinserted into a pre-drilled hole (not shown) but resists being pulledout.

Suture securing portion 470 includes a pair of diametrically opposedcam-operated blades 476 that form an anchor to secure assembly 450 inbone. Blades 476 are movable between a stored position in which blades476 are stored wholly within gaps 464, as shown in FIG. 15 , and adeployed position in which blades 476 extend outwardly of leg portions462, as shown in FIGS. 16-18 .

Each blade 476 includes a sloped cam face 478 that, in a storedposition, extends obliquely relative to a longitudinal axis 480 ofsuture retaining portion 460. A distal end 482 of each blade 476 ispivotally attached to bone insertion portion 490 at a pivot 484, locateddistal of landing 467.

Suture securing portion 470 includes a set screw 479 that is insertableinto internal space 465. Set screw 479 has a blunt distal tip 480 and aproximal head 482 that is configured to accept a driver (not shown) forrotating set screw 479 distally into internal space 465. Set screw 479has an external thread 484 that mate with internal thread 466 to advanceset screw 479 distally.

Bone insertion portion 490 extends distally from suture retainingportion 460 and includes a blunt distal tip 492 and external ribbing 494that is an extension of the external ribbing 468 on suture retainingportion 460.

In an insertion condition, blades 476 are stored within the perimeter ofleg portions 462. A suture (not shown) can be inserted into sutureretaining portion 460 such that each end of the suture extends outwardlyof one of suture slots 468. Bone insertion portion 490 is inserted intothe bone and set screw 479 is advanced distally into internal space 465,engaging cam face 478 of each blade 476 and pushing blades 476 outwardlythrough their respective gap 464 to secure assembly 450 into bone. Asset screw 479 is further advanced distally, set screw 479 engages thesuture and frictionally secures the suture between distal tip 480 andlanding 467.

Alternatively, as shown in FIG. 19 , an anchor 830 includes a distal tip832 with a transverse passage 834 passing through. Anchor 830 also has aproximal end 836 configured to accept a driver (not shown). A body 838having uni-directional ribbing 840 extends from proximal end 836 todistal tip 832.

To insert anchor 830, suture 50 or suture tape 52 (not shown) is passedthrough transverse passage 834 and anchor is tapped into a pre-drilledhole on tibia 40 (not shown). Suture 50 or suture tape 52 is wedgedbetween anchor 830 and the wall of hole.

In an alternative embodiment shown in FIGS. 20 and 21 , an anchor 880includes a cannulated body 882 having an external thread 884. A distaltip 886 includes a transverse, first passage 888 and an oblique, secondpassage 890 proximal of first passage 888. Second passage 890 includes afirst portion 891 that extends obliquely upwardly into an internalcannula 892 and a second portion 894, diametrically opposite from firstportion 891, that also extends obliquely upwardly into internal cannula892. Internal cannula 892 extends from first passage 888 to a proximalend 896 that can include a hex head 898 to accommodate a driver (notshown). The driver can be cannulated to allow a suture to extendtherethrough.

Suture 50 or suture tape 52 is looped through either first passage 888or second passage 890 and passes through cannula 892 to proximal end896.

An alternative embodiment of an assembly 900 is shown in FIGS. 22-24 .Assembly 900 includes a washer 910 and a buckle 920 extending outwardlyfrom washer 910. A suture tape 52 is secured to buckle 920.

Washer 910 includes a generally annular body 912 having a flat topsurface 914 and a tapered inner diameter 916. A circular opening 918 isformed within inner diameter 916 and is sized to allow a fixation screwto be inserted therethrough.

Buckle 920 extends at an upward oblique angle from top surface 914 andincludes parallel side walls 922, 924, a top connecting member 926, anda central connecting member 928 that each span and connect sides 922,924 to each other. A first, lower gap 930 is formed between centralconnecting member 928 and body 912, while a second, upper gap 934 isformed between central connecting member 928 and top member 926.

Referring to FIGS. 22 and 24 , to use assembly 900, two screws 70 withwashers 910 are inserted into tibia 40 so that suture tape 52 can bewrapped around fibula 42. A first end 54 of suture tape 52 is secured toa first buckle 920. A second end 56 of suture tape 52 stretched overfibula 42 and is inserted through lower gap 930 distal from washer 910toward washer 910. Second end 56 is then extended upwardly and over topconnecting member 926 and then inserted through upper gap 934 distalfrom washer 910 toward washer 910. Second end 56 is then insertedthrough lower gap 932, proximate to washer 910 away from washer 910.Second end 56 is then pulled upwardly, tightening suture tape 52 againstfibula 42.

Alternatively, second end 56 can be inserted through gaps 932, 934 priorto securing washer 910 to tibia 40, then securing washer 910 to tibia40, and then tightening suture tape 52 around fibula.

An alternative embodiment includes a screw 1000 shown in FIG. 25 . Screw1000 has a distal tip 1002 and a proximal end 1004. A threaded body 1010can extend between tip 1002 and proximal end 1004. Body 1010 can havevarying outer diameters along the length of body, such as a narrow bodyportion 1012 toward distal tip 1002 and a wider body portion 1014 towardproximal end 1004.

Proximal end 1004 includes a buckle 1030 similar to buckle 920 describedabove with respect to assembly 900. This washerless embodiment allowsbuckle 1030 to be driven sub-flush of the bone cortex. The tensioningmethod for suture tape 52 is the same as for assembly 900 describedabove.

An alternative embodiment of an assembly 1100 is shown in FIGS. 26 and27 . Assembly 1100 includes a washer 1110 with a buckle 1120 thatincorporates a cam 1130.

Washer 1110 includes a generally annular body 1112 having a flat topsurface 1114 and a tapered inner diameter 1116. A circular opening 1118is formed within inner diameter 1116 and is sized to allow a fixationscrew to be inserted therethrough.

Buckle 1120 extends at an upward oblique angle from top surface 1114 andincludes parallel side walls 1122, 1124 and a top connecting member 1126that spans and connects sides 1122, 1124 to each other. Side walls 1122,1124 each include a transverse slot 1128. Connecting member 1126includes a concave inner face 1129.

Each side of cam 1130 includes a pivot portion 1132 that is insertedinto transverse slot 1128 to that cam 1130 can pivot about transverseslot 1128. Cam 1130 also includes a lobe 1134 positioned over that isused to bias suture tape 52 against top surface 1112 of washer 1110 anda slot 1136 through which suture tape 52 is inserted.

First end 54 of suture tape 52 can be fixed to another securing device,not shown. Second end 56 of suture tape 52 can be inserted into gap 1127distal from washer 110 toward washer 1110 and under lobe 1134. Secondend 56 is then inserted through slot 1136 in cam 1130. To secure suturetape 52, cam 1130 is pivoted along concave inner face 1129 from theposition shown in FIG. 26 to the position shown in FIG. 27 . Lobe 1134is rotated to pinch suture tape 52 down on top surface 114, securingsuture tape 52 to assembly 1110.

While assembly 1100 is shown using washer 1110, those skilled in the artwill recognize that buckle 1120 with cam 1130 can be used on othersecuring devices, such as, for example, on screw 1000.

An alternative embodiment of an assembly 1200 is shown in FIGS. 28-32 .Assembly 1200 includes screws 70 that are implanted into tibia 40 oneither side of fibula 42. A suture 50 is attached to each screw 70 sothat each suture 50 has a free end 58. Free ends 58 are drawn overfibula 42 and clamped together, such as by staple 1202. Staple 1202 canbe clamped around free ends 58 by a clamping instrument 1210.

Clamping instrument 1210 includes a pair of arms 1212, 1214 that arepivotally attached to each other at a pivot 1216. Instrument 1210includes a staple receiver 1215 on an opposing side of pivot 1216.Clamping teeth 1218, 1220 are attached to distal ends of arms 1212,1214, respectively on the opposing side of pivot 1216 and on either sideof receiver 1215.

As shown in FIG. 31 , staple 1202 is inserted into receiver 1215. Freeends 58 of sutures 50 are inserted into staple 1202 and arms 1214, 1216are compressed toward each other as shown in FIG. 32 so that clampingteeth 1218, 1220 close down on staple arms 1204 to clamp free ends 58 ofsuture 50 within staple.

An alternative embodiment of an assembly 1300 is shown in FIG. 33 .Assembly 1300 includes a band 1302 that connects two separate sutures 50to each other. Sutures 50 can be secured to a bone (not shown) via anyof the anchors disclosed herein, such that free ends 58 of suturesextend away from the anchors. Band 1302 includes clamps 1304 are eitherend thereof to secure free ends 58 of sutures 50.

Each clamp 1304 includes a body 1306 having a closure 1308 pivotallyattached thereto. Free end 58 of suture 50 can be inserted through clamp1304 between body 1306 and closure 1308. Closure 1308 can be pivoted tobody 1306 to secure suture 50 between body 1306 and closure 1308.

An advantage to using band 1302 is that band 1302 can be slid alongeither suture 50 to a select location prior to securing suture 50 toband 1302 in order to avoid engaging any anatomically challenging areas.

The anchors and assemblies disclosed herein can be constructed frombiocompatible materials, such as stainless steel, titanium, or othersuitable materials or combinations thereof.

It will be further understood that various changes in the details,materials, and arrangements of the parts which have been described andillustrated in order to explain the nature of this device may be made bythose skilled in the art without departing from the scope of the deviceas expressed in the following claims.

What is claimed is:
 1. A syndesmosis fixation assembly comprising: asuture retaining portion having a plurality of fingers, each fingerseparated by a longitudinal gap; a suture securing portion configured tobe received in the suture retaining portion, wherein the suture securingportion has an anchor with anchor legs, each anchor leg configured toextend into one of the longitudinal gaps; and a bone insertion portionhaving: a distal bone insertion end adapted for insertion into a bone; aproximal bone insertion end extending distally from the suture retainingportion; and a central longitudinal axis extending between the distalbone insertion end and the proximal bone insertion end.
 2. Thesyndesmosis fixation assembly according to claim 1, wherein a suture isconfigured to be inserted into suture retaining portion such that eachend of the suture extends outwardly from one of the longitudinal gaps.3. The syndesmosis fixation assembly according to claim 2, wherein thesuture securing portion further includes a set screw configured to bereceived into the suture securing portion.
 4. The syndesmosis fixationassembly according to claim 2, wherein the set screw is configured toadvance into suture retaining portion to cause the anchor tofrictionally engage the suture.
 5. The syndesmosis fixation assemblyaccording to claim 4, wherein the set screw is configured to splay eachanchor leg out of one of the longitudinal gaps as set screw is advancedinto the suture retaining portion.
 6. The syndesmosis fixation assemblyaccording to claim 1, wherein the suture retaining portion and the boneinsertion portion contain external ribbing.
 7. The syndesmosis fixationassembly according to claim 1, wherein the anchor is a spring anchorwith a body portion and the anchor legs extend outwardly from the bodyportion.
 8. The syndesmosis fixation assembly according to claim 3,wherein the set screw has a blunt distal tip.
 9. The syndesmosisfixation assembly according to claim 8, wherein the distal boneinsertion end is blunt.
 10. The syndesmosis fixation assembly accordingto claim 3, wherein the set screw has threads that mate with threads aninternal thread in suture retaining portion.
 11. A syndesmosis fixationassembly comprising: a suture retaining portion; a suture securingportion configured to be received in the suture retaining portion,wherein the suture securing portion has an anchor with anchor legs; anda bone insertion portion having: a distal bone insertion end adapted forinsertion into a bone; a proximal bone insertion end extending distallyfrom the suture retaining portion; and a central longitudinal axisextending between the distal bone insertion end and the proximal boneinsertion end.
 12. The syndesmosis fixation assembly according to claim11, wherein a suture is configured to be inserted into suture retainingportion such that each end of the suture extends outwardly from one of aplurality longitudinal gaps in the suture retaining portion.
 13. Thesyndesmosis fixation assembly according to claim 12, wherein the suturesecuring portion further includes a set screw configured to be receivedinto the suture securing portion.
 14. The syndesmosis fixation assemblyaccording to claim 12, wherein the set screw is configured to advanceinto suture retaining portion to cause the anchor to frictionally engagethe suture.
 15. The syndesmosis fixation assembly according to claim 14,wherein the set screw is configured to splay each anchor leg out of onethe longitudinal gaps as set screw is advanced into the suture retainingportion.
 16. The syndesmosis fixation assembly according to claim 11,wherein the suture retaining portion and the bone insertion portioncontain external ribbing.
 17. The syndesmosis fixation assemblyaccording to claim 11, wherein the anchor is a spring anchor with a bodyportion and the anchor legs extend outwardly from the body portion. 18.The syndesmosis fixation assembly according to claim 13, wherein the setscrew has a blunt distal tip.
 19. The syndesmosis fixation assemblyaccording to claim 18, wherein the distal bone insertion end is blunt.20. The syndesmosis fixation assembly according to claim 13, wherein theset screw has threads that mate with threads an internal thread insuture retaining portion.